Director, Clinical Quality Assurance

Responsibilities

• Author, maintain, and implement study-specific Clinical Quality Audit Plans for assigned clinical programs
• Represent Quality at cross-functional clinical program and Clinical Study Team meetings
• Identify, mitigate, or escalate clinical quality risks using GCP knowledge
• Maintain program oversight regarding vendor management, study conduct, and study lifecycle
• Author and review QMS controlled documents including SOPs in accordance with ICH E6, FDA, and EMA regulations
• Oversee implementation of Deviations, Investigations, and CAPAs
• Conduct QA reviews of essential documents such as Clinical Protocols and Investigator Brochures
• Support the development and deployment of Inspection Readiness/Management programs

Requirements

• Bachelor’s degree in STEM or an allied medical field (Nursing, Pharmacy, etc.)
• Minimum 7 years of pharmaceutical/biotech GCP Quality Assurance or Clinical Compliance experience
• Experience in Phase 1–4 clinical trials including non-interventional studies
• Strong working knowledge of global GxP regulations (FDA, EU, and ICH)
• Direct experience with competent authority inspections (e.g., US FDA GCP BIMO, PAIs)
• Experience in immunology trials is strongly preferred
• Ability to travel domestically and internationally up to 25%

About the Company

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases through innovative, targeted anti-FcRn technology.